Phase 2
N=32
The Use of Heliox in Obstructive Sleep Apnea Syndrome
Obstructive Sleep Apnea Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02135900 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Apnea Hypopnea Index — 42.71; 40.95 Apneas or hypopneas per hour sleep
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Heliox (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index |
42.71; 40.95 | — |
| PRIMARY Apnea Index (AI) |
16.46; 11.26 | — |
| PRIMARY Lowest Oxygen Saturation (L SO2) |
84.22; 90.47 | — |
| PRIMARY Mean Oxygen Saturation (M SO2) |
93.47; 96.29 | — |
Summary
The goals of the project is to evaluate the effects of Heliox therapy on obstructive sleep apnea syndrome (OSAS).
Eligibility Criteria
Inclusion Criteria
- Adults 18 or older with obstructive sleep apnea syndrome (OSAS) presenting for CPAP titration.
Exclusion Criteria
- Professional singers.
- Television or Radio hosts.
- Disk Jockeys.
- Subjects requiring oxygen therapy.
- Subjects younger than 18 year old.
- Pregnant women.
- Patients with chronic obstructive pulmonary disease (COPD) with forced expiratory volume 1 (FEV1) less than 50%.
- History of anatomic upper airway obstruction.
- Uncontrolled asthma.
Data sourced from ClinicalTrials.gov (NCT02135900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.